Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTOG4

Study information

Scientific title

Acronym

Study hypothesis

Five versus eight courses of carboplatin or cisplatin in ovarian cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

Patients are randomised to one of two treatment schedules:
1. Schedule A: Carboplatin or cisplatin repeated every four weeks for a total of five courses. CA125 measurement to be carried out prior to each course.
2. Schedule B: Carboplatin or cisplatin repeated every four weeks for a total of eight courses. CA125 measurement to be carried out prior to each course.

Intervention type

Drug

Phase

Not Specified

Drug names

Carboplatin, cisplatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/12/1989

Overall trial end date

13/04/1994

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed diagnosis of invasive epithelial ovarian carcinoma
2. International Federation of Gynaecology and Obstetrics (FIGO) stage Ic, II, III or IV
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
4. Aged 18 - 75 years
5. Adequate renal, hepatic and bone marrow function
6. Life expectancy of at least 3 months
7. No history of previous malignancy, except basal cell carcinoma of the skin or in situ carcinoma of the cervix
8. No medical contra-indications to protocol treatments

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

237

Participant exclusion criteria

Does not comply with above inclusion criteria.

Recruitment start date

05/12/1989

Recruitment end date

13/04/1994

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/8805927

Publication citations

  1. Rustin GJ, Nelstrop AE, Tuxen MK, Lambert HE, Defining progression of ovarian carcinoma during follow-up according to CA 125: a North Thames Ovary Group Study., Ann. Oncol., 1996, 7, 4, 361-364.

Additional files

Editorial Notes